MAUDE Adverse Event Report: MEDTRONIC, INC. PROGRAMMING HEAD; PROGRAMMER, PACEMAKER

Model Number	2067
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: analysis was able to confirm the customer comment that the radio frequency programming head (rf head) had a telemetry issue and the device cable was found to be damaged.It was further noted that the printed circuit board (pcb) assembly, upper and lower case, magnet, retainer and antenna coil all had corrosion.All found defective parts were replaced and all other identified issues were resolved.The device then passed final functional and system tests.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the radio frequency programming head (rf head) had a telemetry issue and could not read smoothly.The rf head was received into service.There was no patient involvement.It was further reported that the rf head tested out of specification during manufacturer's analysis.

• Brand Name: PROGRAMMING HEAD
• Common Device Name: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10281583
• Report Number: 2182208-2020-01282
• Device Sequence Number: 16332178
• Product Code: KRG
• UDI-Device Identifier: 00721902290121
• UDI-Public: 00721902290121
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 2067
• Device Catalogue Number: 2067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1